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Status unknownNCT00785837hydrotherapyUpdated Nov 5, 2008

Effects of Hydrotherapy in Pain and Quality of Sleep's Cycles in Preterm Newborn on Neonatal Intensive Care Units

An interventional study of Aquatic Physical Therapy in Perinatal Care, sponsored by Universidade Luterana do Brasil. Status unknown at 1 site in Brazil. Open to participants aged Up to 36 Weeks. Per ClinicalTrials.gov, last updated 2008-11-05.

Sponsored by Universidade Luterana do Brasil · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Sep 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
8
Ages
Up to 36 Weeks
Sex
All
01

Study summary

Researchers suggest that the protection of the cycles of sleep is essential for neurodevelopment, learning, memory and preservation of brain plasticity to the individual's life. Recent research shows that technical bath promote reduction of crying, anxiety and improves the behavior of newborns.

Read the detailed description

This was a pilot study assessing the technique in this population. The study was conducted with 8 stable premature infants admitted in the Neonatal Intensive Care Unit (ICU) from Hospital Luterano de Porto Alegre. Physiological and behavioral parameters were assessed by Brazelton's neonatal behavior assessment scale, and the pain was evaluated by NFCS scale. The mean of Brazelton's scale was reduced after the procedures from 5,88 ± 0.35 to 1,38 ± 0.74, p \< 0.001. The score in pain assessment scale was reduced from 5,38 ± 0.91 to 0.25 ± 0.46, p \< 0.001 after intervention. The study suggests that aquatic physical therapy could be a simple and effective method to reduce pain and stress in premature infants admitted in the neonatal ICU.

02

Conditions studied

  • Perinatal Care

Keywords

  • Hydrotherapy
  • Perinatal Care
  • Neonatology
03

In context

Lead sponsor

Universidade Luterana do Brasil is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 36 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • premature infants with gestational age less than 36 weeks,
  • clinically stable, showing behavioral abnormalities such as intolerance to the touch, excessive crying, showing signs of pain in accordance with the scale
  • difficulty of NFCS leave the stage of crying and agitation for a period of deep sleep during a period of not less than 60 minutes.

Exclusion criteria

Exclusion Criteria:

  • premature medically unstable because of the difficulty of monitoring in liquid medium, with a change in temperature on mechanical ventilation who had an infectious process due to the exacerbation of it in hot water, and syndromic children with congenital facial deformities that impede the use of scale NFCS for evaluation.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
8 participants (estimated)

Study arms

  • No intervention
    Before Hidrotherapy
  • Experimental
    Hidrotherapy

    Other: Aquatic Physical Therapy

Interventions

  • OtherAquatic Physical Therapy

    The Physiotherapy was performed with gentle movements in eight shape, from left to right, in addition to movements of unbundling girdle, light and slow the trunk and extremities posture and body by flexing the organization Wrapping the body.

06

What researchers measure

Primary outcomes

  1. Physiological and behavioral parameters were assessed by Brazelton's neonatal behavior assessment scale, and the pain was evaluated by NFCS scale. The mean of Brazelton's scale was reduced after the procedures from 5,88 ± 0.35 to 1,38 ± 0.74, p < 0.001.

    Time frame: At two years

07

Study locations

1 of 1 sites recruiting
  • Universidade Luterana Do Brasil
    Canoas, Rio Grande do Sul 92425-900, Brazil
    Recruiting
    • CARINE M VIGNOCHI, PHD · Contactcarinemv@yahoo.com.br · 51 84510533
    • Carine M Vignochi, Phd · Principal investigator
08

References and documents

Publications

  • Vignochi CM, Teixeira PP, Nader SS. Effect of aquatic physical therapy on pain and state of sleep and wakefulness among stable preterm newborns in neonatal intensive care units. Rev Bras Fisioter. 2010 May-Jun;14(3):214-20. English, Portuguese. PubMed 20730365 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2005, a primary completion of Sep 2008 and a completion of Jan 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2008
First posted
Nov 5, 2008
Start
Jul 2005
Primary completionEst.
Sep 2008
CompletionEst.
Jan 2009
Last update
Nov 5, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 5, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00785837
Lead sponsor
Universidade Luterana do Brasil
First posted
Nov 5, 2008
Start date
Jul 2005
Primary completion
Sep 2008 (estimated)
Completion
Jan 2009 (estimated)
Last update
Nov 5, 2008

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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